Advanced Medical Solutions Ltd admedsol.com

Just in case

GENTA-COLL® resorbCollagen gentamicin spongeHaemostasis +antibiotic protectionagainst infections

REPAIR ANDREGENERATE

... combined with antibacterial protection

GENTA-COLL® resorb is ahaemostatic collagen spongecontaining the aminoglycosideantibiotic gentamicin sulphate,used to protect against infectionsand microbial contamination.The use of collagen of equineorigin ensures the highest levelof product safety.5

The collagen is completelyreabsorbed.8 This eliminates theneed for second-look operations,which are required when usingnon-resorbable materials.The naturally structured collagenfibres activate blood coagulationjust like endogenous collagen.8

• After GENTA-COLL® resorb comes into contact with blood,the platelets aggregate on thecollagen fibres, triggering thecoagulation reaction.

• GENTA-COLL® resorb fills up after insertion of the defect volume and forms a guide forthe tissue response, which promotes the migration and attachment of divisible cells.

• By loosely filling the defect with GENTA-COLL® resorb, theformation of a wound hematoma is prevented, thereby reducing the risk of bacterial colonization of the wound area.

GENTA-COLL® resorb -

a medical product made fromhigh-quality collagen

• Haemostatic• Resorbable• Malleable• Ideal substrate for fibrin glue• Highly absorbent• Structurally stable + elastic in moist wound area

The tried and tested properties of collagen...

2

%100

50

0Variouscellulosepreparations

Variousgelatinepreparations

Variouscollagen fleecepreparations

169

18A B 18 19C D E

F G H

Degree of aggregation5 minutes after contact with various wound dressings(determined by translucency)

90 88 90

Collagen fleecedevices cause a

substantiallyhigher extent ofplatelet aggre-

gation.10

Min.20

15

10

5

0Collagenpowder

Collagenfleece

Gelatinesponge

Oxidizedcellulose

Untreated1,5 1,7

4,5 5

18

Collagen fleece orpowder are proven tobe significantly more

effective than gelatinesponges or cellulose.They are reabsorbed

rapidly and completelyby the body, while the

native collagen additi-onally promotes gra-

nulation and epitheli-zation. Collagen fleecepreparations achieve a

significantly higherdegree of platelet ag-

gregation.

Bleeding time for astandardized spleen wound

"The widely held view that prolonged levels of antibioticsare required in septic bone surgery contrast withgenerally accepted experience."9

Preventing possiblemicrobial contaminationof the collagen sponge

0.5h 2h 6h 1d 2d 3d 4d 5d 6d 7d

0.00

2.00

4.00

6.00

8.00

10.00

Time (hours / days)

�g/ml Serum levels

F 5mgM 5mgM 10mgM 15mg

F = intrafemoralM = intramuscularmg/kg body weight

Gentamicin sulphate belongs tothe aminoglycoside group andhas a broad spectrum antibacte-rial efficacy.For certain antibiotics, e.g. Ami-noglycoside, the highest possibledrug level determines the degreeof bactericidal activity and theduration of postantibiotic effects.It is scientifically undisputed thatsustained lower drug level ofaminoglycosides promote theemergence of resistant bacteriaand are not recommended.High levels are reached initiallyat the implant location followinglocal application but toxic serumlevels in the entire organism arenot reached.One study shows that this typicaleffect is relatively independentfrom the implant environmentand the applied dosage.6

Gentamicin sulphate

according to Scherer6

3

GENTA-COLL® resorbis recommended forblood coagulation• for clean and contaminated

wounds• in septic surgery, e.g. for

revision surgery• in cases where there is a high

risk of infection

GENTA-COLL® resorb can also beused in septic surgery, thanks toits antibiotic content.

... and antiseptic surgery

Case Report

Well equipped for septic...

Case Report (O.L., 58 y, F)

Collagen antibiotic compositesused for deep infection after vas-cular reconstruction

CA Prof. Dr. H. Zühlke

The example shows a 64-year oldpatient with an infected femoro-femoral cross over prosthesis forthe reconstruction of unilaterallyblocked pelvic vessels.Since the whole prosthesis inclu-ding the anastomoses as well asthe common iliac and facial ar-teries were infected, an aggressi-ve approach is indicated and thevascular prosthesis is to be ex-planted.After explantation of the infectedvascular reconstruction and anexcessive wound debridement,the common iliac artery is re-constructed through autogenousvein patch plastic surgery.In addition, GENTA-COLL® resorbis used.The instillation of the collagenantibiotic composite (GENTA-COLL® resorb ) constitutes anindispensable precautionarymeasure in the case of manifestor imminent infections, alongsidefurther biological backup opera-tions such as an omentum trans-position or sartorial surgery aswell as targeted systemic antibio-tic administration.The prophylactic use of GENTA-

COLL® resorb is also recommen-ded as a protective measure at apotentially contaminated implantsite, e.g. for open vascular injuries.On the receiver side (commoniliac artery), the primary blockedaorto-iliac vascular axis must berecanalized through retrogradedisobliteration in order to achievereperfusion of the ischaemiclimbs.Following retrograde disoblitera-tion of the blocked aorto-iliacvascular axis, the arteriotomy isalso closed with a vein patch.Should this method fail, an auto-genous aorto / iliac-femoral greatsaphenous vein (GSV) bypassmust be carried out as an alter-native in order to revascularizethe affected limb.Resorbable suture can be usedon a long-term basis as suturematerial.Additionally, GENTA-COLL® resorbis used during anastomoses andon the implant site in order toensure hemostasis takes placeunder antibiotic protection inanastomoses.In this patient's case, the limbwas effectively revascularizedthanks to this process and theinfection was able to heal.

Case Report (L. Ne, 63 y, F)

Prof. Dr. R. Ascherl

As a result of a skiing accident,the patient is suffering from atrimalleolar dislocated ankle withfracture on the left hand side.

First care:Reduction and application of anon-weight-bearing cast at theresort (site of the accident).After transportation to patient'shome:Haematoma, swelling, extensivesoft tissue damage and tensionblisters.Delayed fracture treatment withscrews and plate osteosynthesisonce swelling has gone downand soft tissue conditions haveimproved.

Healing disorder and infectionin the lateral malleolus and fibulaarea in the fourth postoperativeweek.Open treatment, lavages, debri-dements and in each case, appli-cation of equine collagen genta-micin for hemostasis andantibiotic protection.Peronaeus muscle flaps.Final closure by means of a split-thickness skin graft seven weekspostoperative. Fracture healing.

Rehabilitation of osteitis.Meanwhile, complete rehabilita-tion of minor extension deficits.

Dr. K. D. Stoltze

Department for Spinal SurgeryHematogenous spondylitis, fifthand sixth cervical vertebrae(Staphylococcus aureus) withprevertebral and intraspinalabscess.Progressive infection under con-servative treatment.Incomplete tetraparesis.Surgical treatment of infectionwith abscess drainage and verte-bral body resection.Following microsurgical removalof the abscess membrane anddecompression of dural hemos-tasis and local antibiosis with acollagen gentamicin sponge.Rehabilitation of the defect afterthe radical debridement with atitanium brace, filled and sur-rounded with autologous spon-giosa with added antibiotics.

Alongside systemic therapy, localtreatment of infection is an es-sential complement to systematicsurgical treatment and withoutdoubt a significant factor inachieving infection-free treat-ment and fusions of over 90%.We use an equine collagen spon-ge, combined with fibrin glue ifrequired, for hemostasis and localantibiosis (GENTA-COLL® resorb)and we believe that we are alsoable to avoid complication proneformations of haematoma andresidual cavities.X-rays show the result of infec-tion-free fusion 3 years postope-rative.Regression of tetraparesis withrecovery of ambulatory abilitiesin caudal stressed moderatespasticity.

4

Prof. Dr. med. Rudolf Ascherl

Case Report

Dr. Heppert

2 cerclages were inserted for themedial wound complication.The femur fracture was stabilizedwith a fixator and the femoralneck fracture was stabilized usinga lag screw (fig. 1).This became infected.MRSA was detected as the mic-robial cause.

Following debridement, a reoste-osynthesis with plate was carriedout, but the infection did not goaway.After 2 months of stationary iso-lation (MRSA) with a total of 11revisions, the patient was trans-ferred to our clinic at his ownrequest.The revision revealed that ne-crotic bone in the area of theprevious cerclage had caused amedial and lateral fistula.A segmental resection was per-formed once an external fixatorhad been installed.The defect was filled with anantibiotic spacer (fig. 2)

4 weeks later the spacer wasremoved and a spongioplastywas carried out (fig. 3).

This was mixed with a collagengentamicin sponge.We did not want to risk a trans-lation of bone segments fromthe proximally enclosed lag screw(danger of pin track infection).Due to delayed healing of thefracture, this could not yet beremoved.Due to overdue consolidationdespite successful installation ofthe spongiosa, a stabilization wascarried out using a fixed-angleimplant (fig. 4).

Fig. 1 Fig. 3 Fig. 4 Fig. 5

Fig. 2

The musculus grazilis was raisedand reinforced with stitches.The muscle was then fixed direct-ly onto the bone via a drilledtransosseous channel after theinsertion of a GENTA-COLL®resorb sponge, sealing the cavity.5 months later, the infection ap-pears to have cleared up in bothclinical and chemical analyses.To this day there has been nodetectable reinfection.The radiological image of thehealing process displays a correctaxis and leg length (fig. 5).Perfect osseous knitting of thespongiosa.

This was deliberately fixed at adistance from the debrided bone(internal fixator principle).Due to significant bleeding fromthe bone and in order to avoidreinfection with the infected pla-te, the cavity between the boneand plate was filled with theGENTA-COLL® resorb sponge.The implant was removed afterone year.A short while later a medial fis-tula appeared.A cavity between the bone andthe skin was found to be respon-sible.After several revisions, the remai-ning scar tissue did not manifestany elasticity, so the cavity wasclosed by means of flap surgery.

32 year old man after amotorcycle accident.As well as undergoing anamputation of the forefoot,he has a second-degree openfemur fracture as well as alateral femoral neck fracture

5

Evidence shows that

precisely where perfect,

controlled haemostasis

takes place,

the wound healing

process is particularly

favourable.

Dry implantation• Moistening GENTA-COLL®

resorb sponges before imp-lantation reduces its hemo-static effect.

• Moistening can lead to prema-ture dissolution of the water-soluble gentamicin sulphate.

Insert loosely

Available on varioussizes

• Do not compress, dress the wound loosely.

Drainages

Removal not necessary

Fibrin glue*

• A second-look operation to remove GENTA-COLL® resorbis not necessary, as the colla-gen is completely reabsorbed.

Clinical applicationsinclude:

Traumatology / orthopedics

• Soft tissue wounds• Abscess cavities• Joint empyema• Spongioplasty• Osteitis• Periprothetic infections• Prosthesis replacement• Discitis• Diabetic foot

General surgery

• Rectal extirpation• Occlusion of the perineal region• Anorectal injuries• Pilonidial cysts• Parenchymatous organs in danger of

becoming infected• Abscess cavities• Contaminated soft tissue wounds• Definitive abdominal closure in the case

of peritonitis after stage-by-stagelavage

Heart and thorax surgery

• Sternotomy• Pacemaker replacement

6

Debridement• Before inserting GENTA-COLL®

resorb into the wound, a ra-dical debridement must be car-ried out.

• Suction and rinse drainage procedures can result in a rapidelimination of antibiotics, re-ducing the level of protectionagainst infection.

• Drainage pores can become blocked with collagen compo-nents.

• The available sponge sizes canbe cut to any size as required.

• GENTA-COLL® resorb is an ideal substrate for fibrin glue.

*Please refer to instructions

GENTA-COLL® resorb

can also be used in

septic surgery,

thanks to its

antibiotic content.

with a wide range of applications

Easy to use

X-ray photograph of acollagen sponge

GENTA-COLL® resorbis resorbable;a second operationfor removal is notnecessary.

7

Proven characteristics of the collagen sponge...

• haemostyptic• resorbable• malleable• highly absorbent• structurally stable and resilient in

the moist environment of the wound

• biocompatible• promotes healing of the wound• osteoconductive• biological matrix

... combined with the antibiotic protectionof gentamicin:

GENTA-COLL®

Is recommended for hemostasis

• for clean and contaminated wounds• in septic surgery, e.g. revision surgery• in cases where there is a high risk of infection

8

1 sponge,2.5 x 2.5 x 0.5cm contains:Collagen made from horsesinew 17.5 mgGentamicin sulphate 12.5 mgof which6.91 - 8.94 mg gentamicin.

GENTA-COLL® resorb

Just in case:

Images in original size

10 x10 cm

5 x 20 cm

1 sponge,10 x 10 x 0.5cmor 5 x 20 x 0.5cmcontains:Collage fibrils of equineorigin 280 mgGentamicin sulphate 200 mgof which110.5 - 143 mg gentamicin.

1 sponge,5 x 5 x 0.5cm contains:Collagen made from horsesinew 70 mgGentamicin sulphate 50 mgof which27.62 - 35.75 mg gentamicin.

5 x 5 cm

2.5 x 2.5 cm

Recommended dosage:*Depending on the size of the defect and the patient's body weight, the following dosages are recommended:

For patients up to 50 kg:1 – 3 GENTA-COLL®resorbin size 10 x 10 cm or 5 x 20 cm.

For patients over 50 kg:Maximum 5 GENTA-COLL®resorbin size 10 x 10 cm or 5 x 20 cm.For smaller defects:GENTA-COLL®resorbin size 5 x 5 cm or 2.5 x 2.5 cm.*Please refer to instructions for use

tamicin - comparison of bioa-vailability and histiological re-actions in animal testing].Unpublished.

7 Stemberger A., Fritsche H., etal (1978):Fibrinogenkonzentrate und Kollagenschwämme zur Ge-webeklebung [Fibrinogen andCollagen Sponges for Tissue Sealing]. Med. Welt 29 (17):720 - 724

8 Stemberger A., Lehner S., OdarJ. (1999):Biodegradable surgical wounddressings -Stability, elasticityand tear resistance as markersof quality.Authorized translation from Ellipse 15 (4): 101 - 105

9 Grimm H. (1989):Lokale antibakterielle Therapiein der Traumatologie? [Local antibacterial therapy in trau-matology?]Forum Traumatologie Osteitis-Therapie, Essex Pharma GmbH

1 Craig W.A., Leggett J., TotsukaK., Vogelman B. (1988):Key pharmacokineticparameters of antibiotic effi-cacy in experimental animal infections.J. Drug Dev., 1 (S3): 7 - 15

2 Grimm H. (1989):Bakteriologische und pharma-kokinetische Aspekte der topi-schen Antibiotikaanwendung.Kollagen als Wirkstoffträger [Bacteriological and pharma-cokinetic aspects of topical antibiotic application.Collagen as a drug carrier.]Einsatzmöglichkeiten in der Chirurgie [Possible applicati-ons in surgery].Ed.Stemberger A., Ascherl R.,Lechner F., Blümel G., Schattauer Verlag, Stuttgart New York, 33 -37

3 Mendel V. (Hrsg.), Beyer M. (co-author) (1989): Knochen-

und Weichteilinfektionen[Bone and soft tissue infec-tions]. Perimed textbookpublishing companyISBN 3-88429-341-9

4 Moore R.D., Lietman P.S., Smith C.R. (1987): Clinical response to aminoglycoside therapy:Importance of the ratio of peak concentration to minimalinhibitory concentration.The Journal of Infectious Di-seases 155 (1): 93 - 99

5 Ph. Eur. Supplement to the European PharmacopoeiaSupplement 2000 (2000):5.2.8 Minimization of the riskof the transmission of trans-missible spongiform encepha-lopathies in traditional medi-cines and health supplements.Ph.Eur.- Supplement 2000

6 Scherer M.A. (1996) Munich:Resorbierbare Arzneistoffträ-ger aus Kollagen mit Gentami-cin - Vergleich der Bioverfügbarkeit und der his-tologischen Reaktion im Tier-versuch [Resorbable active pharmaceutical ingredients made from collagen with gen-

Literature

9

GENTA-COLL® resorb

10Stemberger A., Ascherl R., Scherer M.A., Kaufer C.,Pfeffer M., Blümel G. (1992)Hämostyptika in der Chirurgie-in vitro Untersuchungen zurStimulierung der Blutgerin-nung sowie Festigkeit in Kom-bination mit Fibrinklebung [Hemostasis in surgery - in vitro studies to stimulate co-agulation and solidity in com-bination with fibrin glue].Ed. Gebhardt C (ed.) Fibrinkle-bung in der Allgemein- und Unfallchirurgie, Orthopädie, Kinder- und Thoraxchirurgie [Fibrin glue in general and trauma surgery, orthopedic, children's and thorax surgery],Springer Verlag, Berlin, pp 27-36

11Sources:Images from a table by Sil-verstein ME, FACS, Chvapil M(1981) Experimental and clini-cal experiences with collagenfleece as a hemostatic agent

Sources 2, 4 and 9 refer to aminoglycoside gentamicin sulphate.

Sponge size Pack contents REF

2.5 x 2.5 cm 1 sponge GC125

2.5 x 2.5 cm 5 sponges GC525

5 x 5 cm 1 sponge GC15

5 x 5 cm 5 sponges GC55

10 x 10 cm 1 sponge GC110

10 x 10 cm 5 sponges GC510

5 x 20 cm 1 sponge GC1520

Class III medical device

GENTA-COLL® resorb

Instructions for use

10

Collagen sponge with antibiotic protec-tion for surgical use- haemostatic, sterile -

COMPOSITION

1 sponge 2.5 x 2.5 x 0.5 cm contains:Collagen from equine tendons17.5 mg Gentamicin sulphate 12.5 mgcorresponding to 6.91 – 8.94 mggentamicin1 sponge 5 x 5 x 0.5 cm contains:Collagen from equine tendons 70 mgGentamicin sulphate 50 mgcorresponding to 27.62 – 35.75 mggentamicin1 sponge 10 x 10 x 0.5 cm or5 x 20 x 0.5 cm contains:Collagen from equine tendons 280 mgGentamicin sulphate 200 mg correspon-ding to 110.5 – 143 mg gentamicin1 cm2 sponge 0.5 cm in thickness con-tains: Collagen from equinetendons 2.8 mg Gentamicin sulphate2 mg corresponding to 1.10 – 1.43 mggentamicin

PHARMACEUTICAL FORM

Absorbable implant

INDICATIONS

GENTA-COLL® resorb is indicated forlocal haemostasis of capillary bleedingfrom parenchymatous tissue in regionswith a high risk of infection.GENTA-COLL® resorb may be applied indefect cavities and other residualcavities during surgery, as for examplein the sacral cavity after rectum ampu-tation, or for soft-tissue abscesses re-sulting from pilonidal sinuses. GENTA-COLL® resorb may be applied for hae-mostasis in clean, clean-contaminatedand contaminated wound cavities in thepresence of diffuse, capillary, arterio-venous, or arterial or venous bleeding,extensive capillary bleeding from paren-chymatous organs, or as a supportivemeasure for other procedures for hae-mostasis. GENTA-COLL® resorb may alsobe applied in combination with fibrinadhesives.

DOSAGE AND ADMINISTRATION

After removing the focus of inflamma-tion GENTA-COLL® resorb is appliedinto the defect cavity as required. GENTA-COLL® resorb is loosely inserted as a flatsponge – either rolled or folded – or, incases of bone defects, applied mixedwith bone chips. The collagen sponge isabsorbable and need not be removed.Haemostasis occurs on a physical basis.The contact of collagen with blood leadsto aggregation of platelets which preci-pitate in large numbers on the collagenmatrix, disintegrate, and release clottingfactors which, together with plasmafactors, facilitate the formation of fibrin.The collagen matrix gives additionalreinforcement to the blood clot.Due to its structure GENTA-COLL® resorbis capable of absorbing large quantitiesof fluid. During this purely mechanicalprocess of absorption of secretion, re-jected materials such as bacteria andfibrin clots are also removed.This accelerates the formation of granu-lation tissue.The size of the defect and the weight ofthe patient determine the dosage ofGENTA-COLL® resorb. Subject to theseparameters, 1 to 3 sponges (10 x 10 cm)are generally applied for patients up to50 kg, or a maximum of 5 sponges (10x 10 cm) for patients over 50 kg bodyweight. With smaller defects the spongeis tailored accordingly, or an appropriatenumber of GENTA-COLL® resorb spongesof the size 5 x 5 cm or 2.5 x 2.5 cm maybe used.GENTA-COLL® resorb is applied in a drystate with light pressure to achieve betteradhesion. Because of the affinity of col-lagen to bleeding surfaces, dry instru-ments and glovess hould be used whenapplying GENTA-COLL® resorb.The release of the incorporated genta-micin occurs simultaneously withthe dissolving of the collagen sponge.This protects the implant from externalcontamination by bacteria ascendingalong the drainage as well as from con-tamination by bacteria spread or intro-duced during the surgical procedure. Incases of diffuse bleeding (e.g. in the

sacral cavity) it may prove useful to applythe implant by pressing it onto the af-fected areas of the wound. Overpackingthe wound with collagen may result inthe formation of a seroma. Care shouldbe taken to apply the sponges into thewound area in single layers only.When using GENTA-COLL® resorb in com-bination with a fibrin adhesive, apply theadhesive to the surface of the spongewhich will lie against the area being tre-ated.

CONTRAINDICATIONS

GENTA-COLL® resorb must not be usedin patients with a known hypersensitivityto collagen and/or gentamicin or otheraminoglycoside antibiotics.GENTA-COLL® resorb should only be usedas an adjunct to other procedures forhaemostasis in the presence of bleedingrequiring control by ligatures or in in-stances of larger arterial and/or venoushaemorrhage requiring suture ligatures.

WARNINGS

GENTA-COLL® resorb should only be usedwith strict medical indications in patientswith impaired renal function as well asin patients with autoimmune diseases orneuromuscular diseases such asParkinson‘s or myasthenia gravis.Although toxic serum levels are not rea-ched during the use of GENTA-COLL®

resorb, both plasma gentamicin levelsand plasma creatinine levels should bemonitored. The concomitant systemicadministration of aminoglycoside antibi-otics should be avoided or these shouldonly be given under strict monitoring ofserum gentamicin levels and renal func-tion. Cross-sensitivity to aminoglycosideantibiotics do exist. There is no reportedexperience with the use of GENTA-COLL®

resorb in patients with immunological orconnective tissue diseases. Although ithas not been proven that the use of ani-mal collagen results in exacerbation ofthe disease, GENTA-COLL® resorb shouldonly be used with strict medical indicati-ons in these patients.There is no reported experience with theuse of GENTA-COLL® resorb in children.

SPECIAL PRECAUTIONS FOR USE

To guarantee full efficacy of the product,conventional procedures for theapplication of a haemostatic agentshould be observed. For the risk-freeuse of GENTA-COLL® resorb the followingprecautions for use should be observed:- Soaking or moistening GENTA-COLL®

resorb prior to implantation mayresult both in a loss of efficacy of itshaemostatic properties as well asin a loss of its self-protective propertythrough premature precipitationof the mildly watersoluble gentamicinsulphate. A reduction in thesponge’s blood absorption capacity following the soaking of GENTA-COLL® resorb results in a reduction of the physical properties of plateletaggregation and thus to decisive in-terference with haemostasis.

- The desired platelet aggregation is also achieved by lining the woundwith GENTA-COLL® resorb.

- The simultaneous insertion of a suc-tion and irrigation drain is strictlyprohibited as this would rapidly eli-minate the antibiotic gentamicin andlead to reduced protection by the collagen sponge against infection.The drain openings may also becomeblocked by fragments of collagen.

- GENTA-COLL® resorb should not be used alone. An additional antibioticshould be administered systemically.

INTERACTIONS WITH OTHER MEDI-CINALPRODUCTS

Although only very low plasma levelsare reached after implantation ofGENTA-COLL® resorb, the interaction ofgentamicin with other medicinalproducts should be considered.The concomitant administration of ami-noglycosides with loop diuretics,e.g. furosemide or etacrynic acid, shouldbe avoided because loop diureticsthemselves have an ototoxic effect. Ifdiuretics are simultaneously administe-red intravenously, they may increase theconcentration of gentamicin in serumor tissue and thus increase toxicity.The simultaneous or consecutive or to-

11

pical application of potentially neurotoxicand/or nephrotoxic substances, e.g. cis-platinum, other aminoglycosides, strep-tomycin, cefaloridine, viomycin, polymy-xin B or polymyxin E, may increase thetoxicity of gentamicin. The simultaneoustopical use of -lactam antibiotics mayresult in altered activity (inactivation).The neuromuscular blocking tendencymay be increased by the simultaneousapplication of muscle relaxants, e.g.d-tubocurarine, suxamethoniumor pancuronium, as well as by ether.A neuromuscular blockade can best bereversed by the administration of calciumsalts. Should a neuromuscular blockadeoccur under the simultaneous applicati-on of suxamethonium in the presenceof acquired or genetically determinedcholinesterase deficiency, then artificialrespiration will be necessary and cho-linesterase must be administered.

PREGNANCY AND LACTATION

No data on the safe use of GENTA-COLL®

resorb during pregnancy and lactationare available.Aminoglycoside antibiotics cross theplacenta and reach the fetus. Thereis therefore a risk of intrauterine fetaldamage.Since aminoglycoside antibiotics alsopass into breast milk, GENTA-COLL®

resorb should also not be used duringlactation, or breastfeeding should beceased.

EFFECTS ON ABILITY TO DRIVE ANDOPERATE MACHINES

None known as yet.

ADVERSE REACTIONS

There may be increased secretion onceGENTA-COLL® resorb commencesin the tissue. Overflow drains shouldtherefore be used wheneverpossible in cases of extensive infected

cavities. Nephrotoxicity and ototoxicitymay be potentiated by the simultaneoussystemic administration of aminoglyco-side antibiotics or in patients withimpaired renal function.

OVERDOSE

There is no appreciable increase in serumgentamicin levels when the recommen-ded amounts of GENTA-COLL® resorb areapplied. There is no information availableon doses above these levels.Plasma gentamicin levels and renal func-tion should always be monitored whendoses other than those recommendedare given. Peritoneal dialysis or haemo-dialysis should be considered in cases ofsevere intoxication.

INCOMPATIBILITIES

None known as yet.

PLEASE NOTE:

Because of the affinity of collagen tobleeding surfaces, dry instrumentsand gloves should be used when applyingGENTA-COLL® resorb.GENTA-COLL® resorb has a double-sterilepeel package. The inner package is insideand outside sterile and may be placedon the sterile field.

STORAGE

Do not store above 25 C. Protect frommoisture. Keep out of the reach of child-ren.

SHELF LIFE, STERILITY

The expiry date and the batch numberare imprinted on the retail packand on the cover of the blister pack.GENTA-COLL® resorb must not beused after the expiry date. GENTA-COLL®

resorb sponges removed fromthe protective package must not be res-

terilised and should therefore bediscarded. The contents of unused, yetopened or damaged, packetsmust not be resterilised and should there-fore be discarded. GENTA-COLL® resorb isintended for single use only.

PACK SIZES

Pack with 1 sponge of 6.25 cm2

(2.5 x 2.5 cm) REF GC125

Pack with 5 sponges of 6.25 cm2

(2.5 x 2.5 cm) REF GC525

Pack with 1 sponge of 25 cm2

(5 x 5 cm) REF GC15

Pack with 5 sponges of 25 cm2

(5 x 5 cm) REF GC55

Pack with 1 sponge of 100 cm2

(10 x 10 cm) REF GC110

Pack with 5 sponges of 100 cm2

(10 x 10 cm) REF GC510

Pack with 1 sponge of 100 cm2

(5 x 20 cm) REF GC1520

MANUFACTURERRESORBA Medical GmbHAm Flachmoor 16 · 90475 Nürnberg

Stand 2016-12

DESCRIPTION OF THE SYMBOLS USEDON THE PACKAGE

Reference number

Batch number

Use by year - month

Consult instructions for use

Do not reuse

Do not resterilize

Do not use if package is damaged

Sterilised using ethylene oxide

Upper limit of temperature

HIBC code

Keep dry

CE marking and identification number of the notified body. Pro-duct conforms to the essential requirements of the Council Direc-tive 93/42/EEC concerning medicaldevices

LOT

STERILE R

0197

0197

2017. Resorba is a registered trademark and company of Advanced Medical Solutions Ltd.

P129

3 2

018-

02

RESORBA Medical GmbH, Am Flachmoor 16, 90475 Nürnberg, GermanyTel: +49 9128 / 91 15 0 Fax: +49 9128 / 91 15 91 Email: infomail@resorba.com www.resorba.com